Supervisor, Manufacturing Operations (Second Shift)

Role: Manufacturing Operations Supervisor within Cell Manufacturing, overseeing GMP cell processing for adherent and suspension cultures. Objectives include building and leading a team of 2-8 personnel to produce clinical cellular products in compliance with cGMP standards. Responsibilities encompass personnel hiring, training, scheduling, ensuring GMP compliance, managing projects, and acting as a technical SME for troubleshooting and process improvements. Key duties involve oversight of quality systems, document review, equipment management, and cross-functional collaboration. Requirements: minimum 3 years of cell culture experience, extensive GMP expertise, knowledge of bioreactor technology, and 0-2 years supervisory experience. Knowledge of federal GMP requirements (21CFR 210,211; 820) and cell processing technologies essential. Preferred skills include leadership in GMP environments, experience with clinical-material production, and proficiency with electronic quality systems. Work setup is on-site, working the second shift, with physical tasks in a cleanroom environment involving occasional heavy equipment handling and use of cryogenic gases. The role emphasizes leadership, compliance, technical troubleshooting, and cross-functional collaboration to support cell therapy manufacturing.